Proficient in LIMS configuration, system, and ability to serve as a subject matter expert in this arena. Supports management for activities related to interviewing/training, compliance with policies, providing feedback for personnel development, effective, technical support during audits/inspections and timely decision making/corrective actions. The Sr. Associate II should have a mature leadership approach and understanding of their personal communication style and manage that effectively.

• Collaborate with business subject matter experts to define and document new or revised LabWare requirements.  Draft necessary requirement and verification/qualification documentation.  Communicate requirements and programming needs to IT and other LabWare technical developers.
• Perform configuration of basic and advanced LabWare objects including, but not limited to:  Specifications, Analyses, Batch Templates, Calculations, Format Calculations, Code Snippets, Visual Workflows, Queries, and Various Templates (ELN Experiments, ELN Experiment Workbooks, Stability, Sample Login, Standards and Reagents).
• Execute qualification or verification testing to support final implementation of LabWare configuration additions/revisions.
• Team Lead responsibilities: Assist the LabWare business owner or QC LIMS Support Team Lead in the prioritization, scheduling, and coordination of LabWare related projects and tasks. Provide training and day-to-day support to new and existing employees. Support the identification, definition, and implementation of more efficient processes around LabWare design and change management. Assist in the development of system design standards and best practices. Communicate project status, issues, schedule, and accomplishments to various management and stakeholder groups, as needed.
• Troubleshoot issues between instruments and LIMS and address complex LIMS issues by reviewing logs, code and testing in lower environments.

• Minimally BA/BS in Life Sciences with 5+ years of relevant industry experience required.
• In-depth knowledge and working experience of Labware LIMS, ELN, analytical laboratory operations, understanding quality system and directives required.
• Excellent technical writing, presentation and communication skills.
• Conducts approval of complex reports, data of others.
• Leads complex problem solving through facilitation/escalation.
• Conducts impact assessment related to compliance (global directives, audit finding/readiness, deviations).
• Understanding of impact to project.
• Formulates solutions/options for team and reaches out externally to regulatory/global teams/sites for alignment.
• Mature leadership approach and understanding of their personal communication style and manage that effectively.
• Assists in setting/reporting measurable goals & targets and mitigation plans, as appropriate.
• Mentors junior members of team in quality systems, process improvements.
• Leadership competencies include follow up, decision making, communication, collaboration, and innovation.

The Sr Associate II, Quality Systems is responsible for contributing to key functional, tactical, and operational aspects of the QC LIMS group at Biogen.  Their primary function is to gather and refine user requirements, communicate requirements to LIMS technical developers, and execute verification testing of new/revised LabWare configuration, and to provide scheduling/coordination of these activities by other QC LIMS Support team members.